Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

Comparison Between Erector Spinae Plane Block and Spinal as Surgical Anesthesia and Analgesia in Percutaneous Nephrolithotomy Patient : Conversion to General Anesthesia, Interleukin-6, Postoperative Pain and Opioid Consumption

This study aimed to compare the Effectiveness of Erector Spinae plane block to Spinal as a surgical anesthesia and analgesia in Percutaneous Nephrolithotomy patient

Study Overview

• Status: Recruiting
• Conditions: Incidence Conversion to General Anesthesia, Interleukin-6, Total Tramadol Consumption and Pain Score After Surgery
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Spinal anesthesia

Detailed Description

Thirty subjects (who meet all inclusion criteria and do not have exclusion criteria) are given informed consent before enrolling the study and randomized into two groups: erector spinae plane block and spinal. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry will be set on the subjects in the operation room. Peripheral venous blood samples will be taken for IL-6 examination. All patients will be sedated using Target Controlled Infusion with propofol (Schnider model, effect site) to obtain mild-moderate sedation prior to the block. On Erector Spinae Plane group, single-shot ultrasound guided block will be performed on the operated side with stimuplex 100 mm needle and 25 ml of isobaric bupivacaine 0.5% with epinephrine 1:200.000 will be administered at level Th 9. On the Spinal group, spinal anesthesia will be performed on lateral decubitus position at the level of L3-L4 or L4-L5 and hyperbaric bupivacaine 0.5% 16-18 mg will be given as regimen. Prior to urethral manipulation, all subjects will be given fentanyl iv 50 mcg and sedation with TCI Propofol will be maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping with a scalpel at the level of the incision before the surgery. The ESP block was considered successful in providing surgical anaesthesia when there was no movement and significant changes in vital signs during skin clamping and throughout the surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pry P Pryambodho, doctor; Phone Number: 0213143336; Email: bungsu.ragil@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo Hospital
      • Contact: Pryambodho Pryambodho; Phone Number: +628158816777; Email: pryambodho.pry@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years old and above
• ASA 1,2 and 3
• Patient who will undergo elective supine Percutaneous Nephrolithotomy

Exclusion Criteria:

• Patient who does not agree to be included in the study
• BMI <18.5 kg/m2 or > 40 kg/m2
• Patient with single functional kidney
• Patient who is contraindicated for local anesthetics
• Patient who has severe heart disorder
• Patient with communication disability and cognitive disorders
• Patient with chronic pain with history of high opioid consumption and or alcohol addiction
• Pregnant patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Erector Spinae Plane Block; Patient will receive single-shot ultrasound-guided erector spinae plane block at the level of T9 on the side which will be operated on.	Procedure: Erector Spinae Plane Block; The block will be performed at the level of T9 on the site that will be operated and patient will be given Bupivacaine isobaric 0.5% 25 ml with epinephrine 1:200.000; Procedure: Spinal anesthesia; Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5
ACTIVE_COMPARATOR: Spinal Anesthesia; Patient will receive spinal anesthesia at the level of L3-L4 or L4-L5	Procedure: Erector Spinae Plane Block; The block will be performed at the level of T9 on the site that will be operated and patient will be given Bupivacaine isobaric 0.5% 25 ml with epinephrine 1:200.000; Procedure: Spinal anesthesia; Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence conversion to general anesthesia	This outcome will be measured based on the concentration of propofol needed throughout the surgery. If the concentration of propofol exceeds 3.5 mcg/ml, anesthesia will be converted to a general anesthesia.	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin -6 plasma concentration	Interleukin 6 will be measured 3 times, before surgery, 6 hours after surgery and 24 hours after surgery.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Pry P Pryambodho, Doctor, Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (ACTUAL): July 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Erector Spinae Plane Block; Percutaneous Nephrolithotomy; Visual analog scale; Interleukin-6, Effectiveness; Tramadol patient controlled analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IndonesiaUAnes106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No